Senior QA Specialist, Quality Systems | Seattle, WA
Just is seeking a highly-motivated QA Specialist within the Quality Systems (QS) group that desires to be part of a team focused on improving worldwide access to Biotherapeutics! The role is responsible for supporting a variety of functions within the QS organization including (but not limited to): Document Management, Change Control, and EQMS/LIMS administration. This main purpose of this role is to not only support the day-to-day GMP manufacturing activities through the management of paper documents, but also support the growth and expansion of other QS functions.
- Manage the overall controlled document lifecycle including generation, approval, revision, archival, and obsolescence.
- Write and revise manufacturing documents, including but not limited to Batch Records, Quality Control methods, Manufacturing labels, Material Specifications, and Standard Operating Procedures (SOPs).
- Apply process/equipment expertise and solid understanding of applicable cGMP regulations to provide Quality oversight for GMP changes
- Collaborate with departments to ensure review of changes is executed efficiently and effectively
- Learn and become an administrator for the Just-Evotec EQMS and/or LIMS system in order to drive process improvements, support new user training, and ensure workflows align with GMP regulations and guidelines.
- Support inspection readiness activities, Health Authority and Client audits, and drive corrective actions based on audit findings.
- Manage archival of manuals, documents, and other GMP related documents that require conversion to electronic format.
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
- Provide input to the development of personal performance goals
- Train internal groups on relevant business processes
- Sign documents for activities as authorized and described by Just policies and procedures
- Perform tasks as requested by leadership to support Quality oversight activities
Qualifications and Educational Requirements
- B.S. or M.S. degree, preferably in Engineering, Life Science, or an equivalent combination of education and experience in the Biopharmaceutical Industry.
- 3-5+ years of relevant experience in a Biopharmaceutical cGMP manufacturing or similar environment.
- Word processing software certification or advanced experience using Microsoft Word software.
- Sound knowledge of cGMPs and Document Control guidelines set forth in ICH Q7 and Q10
- Experience with GMP biologics manufacturing processes and equipment.
- Ability to communicate issues, ideas and results clearly and professionally in a comprehensive and concise manner both in writing and verbally. Ability to explain complex issues and concepts with simplicity to a broad audience.
- The ability to work both independently and collaboratively with scientific and engineering staff across multiple disciplines in a fast-paced and dynamic environment.
- Significant experience navigating and managing various modules in a Quality Management System software suite.
- Strong focus on Quality and attention to detail.
About Just – Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood – the center of Seattle’s medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 200 employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers
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